Kornimate/medical-research-clean huggingface dataset:
a randomized clinical trial comparing surgisis afp to advancement flap for the repair of anal fistulas

Conditions: Anal Fistula

Summary: the purpose of this study is to determine whether the surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.


Eligibility criteria:
inclusion criteria: * over eighteen years old * clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature * pre-placement of seton required for at least 6 weeks prior to surgical treatment * willing to sign informed consent and share data with study sponsor and surgisis afp manufacturer exclusion criteria: * recurrent fistula tracts * j-pouch fistulas * superficial fistulas * fistulas with active abscess, infection, or acute inflammation * history of chron's disease * history of ulcerative colitis * history of hiv or other immune system disease * history of collagen disease * history of radiation to the anorectal region * allergies to pig tissue or pig products * religious or cultural objection to the use of pig tissue

Keywords: anal fistula fistula in ano anorectal fistula
effectiveness and mechanism of online peer companion intervention on children with autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the goal of this interventional study was to examine the effectiveness and mechanism of online peer companion intervention (opci) on the social abilities and mental health of asd children. the main questions it aims to answer are: 1. whether opci is effective on the social abilities and mental health of asd children; 2. what impact does opci have on the social abilities and mental health of ordinary children; 3. what impact does opci have on the mental health of both children's parents; 4. what are the mechanisms of opci on asd children.


Eligibility criteria:
inclusion criteria of asd children: * 7-15 years old and diagnosed as mild asd; * basic ability to speak independently and fluently communicate with peers; * could use mobile phones, tablets, computers, or other electronic devices for this online intervention. exclusion criteria of asd children: * diagnosed as moderate or severe asd; * unable or unwilling to communicate with peers independently * no phones or other alternative electronic devices for the intervention inclusion criteria of ordinary children: * 9-18 years old with normal development, no diagnosis of asd, learning disabilities, adhd, and other mental disorders; * lively and outgoing, able to assume the role of topic organizer in communication with peers; * could use mobile phones, tablets, computers, or other electronic devices for this online intervention. exclusion criteria of ordinary children * diagnosis of asd or other neurodevelopmental and mental disorders; * introverted or unwilling to play with peer asd children * no phones or other alternative electronic devices for the intervention

Keywords: autism spectrum disorders peer-mediated intervention children
nursing and nurturing premature infants

Conditions: Infant Growth; Mothers' Parental Competence

Summary: the purpose of this study is to determine whether systematic use of the newborn individualized developmental care assessment program (nidcap®) improves the neurologic development of children and the parental competence of mothers.

background: the unborn infant's brain is growing from the fifth month of fetal life which makes preterm babies sensitive to environmental influence. therefore, to prevent developmental brain injury is an essential goal for neonatal nurses. purpose: the study investigates whether systematic use of newborn individualized developmental care assessment program (nidcap®) improves the neurological development of preterm babies and the parental competence of mothers. design: this study compares postnatal care of preterm babies in two neonatal units. participants: preterm infants born before 32 weeks' gestational age and their mothers. instruments: * preterm babies' behaviour in intervention and control groups is observed every 7-12 days using scoring sheets. * questionnaires focusing on maternal self esteem when the baby is 4 weeks and again at 3 and 18 months and 5 years. expected outcomes: * infants: less time with treatment using cpap and oxygen, growth, time of discharge and pattern of motor behaviour. * mothers: self reported experiences of self esteem. analysis: t-test expected implications: in a health promotion perspective the systematic nidcap program hopefully will constitute a more competent mother, knowledgeable in child care and parental management. the intervention nidcap®-care infant group is expected to increase in growth compared to the control group, their motor system will be more mature, and there will be an earlier discharge, all factors contributing positively to health economy.

Eligibility criteria:
inclusion criteria: * premature infants * the infants' biological mothers exclusion criteria: * premature infants with chromosomal anomaly * mothers who cannot read and understand danish

Keywords: preterm infant; nidcap; neonatal care, intervention study; growth and development; maternal self-esteem. maternal social support nicu
study of sta-5326 mesylate in patients with moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: sta-5326 is an oral experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells. given this activity on the immune system, sta-5326 mesylate is a potential treatment for various autoimmune diseases, such as crohn's disease, that are mediated by the inappropriate expression of th1 cytokines. this study is evaluating the use of sta-5326 mesylate in patients with moderate to severe, active crohn's disease. study visits include a screening visit, 4 treatment period visits over 4 weeks and a follow-up visit that will occur 7 days following the end of treatment. subjects may continue treatment for an additional 4 weeks of open label sta-5326 mesylate administration that includes an additional 2 treatment period visits. subjects will undergo a colonoscopy with biopsy collection at baseline, at the end of the 4 week blinded phase and at the end of the 4 week open label phase.


Eligibility criteria:
inclusion criteria: * is male or female aged 18 through 75 years. * has crohn's disease diagnosed definitively prior to screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments). * has a cdai score of 220 to 450, inclusive at baseline. exclusion criteria: * has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this study. * is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and follow-up period. * is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and follow-up period. * has clinically significant hematologic, hepatic or renal laboratory abnormalities.
negative pressure wound therapy vs standard care dressing

Conditions: Negative-Pressure Wound Therapy

Summary: a comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing

the aim of our study is to compare the efficacy of negative pressure wound therapy (prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.

Eligibility criteria:
inclusion criteria: * consent for participation from the patient or his legal representative exclusion criteria: * currently infected wounds * patients with history of immunosupression * pregnancy
effect of vitamin d supplementation on chemotherapy side effects after adjuvant chemotherapy for breast cancer

Conditions: Vitamin D; Chemotherapy; Breast Cancer; Adverse Reaction

Summary: this randomized controlled phase iii trial was designed to evaluate the effect of vitamin d supplementation (vd) on chemotherapy side effects following adjuvant chemotherapy in breast cancer

this is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin d supplementation (vd) in adjuvant chemotherapy in patients with breast cancer. both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. in addition, vitamin d2 will be given randomly to both groups. blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. the primary outcome to be documented was associated grade iii or higher adverse events during adjuvant chemotherapy. primary and secondary study findings and adverse events will be thoroughly evaluated.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years, with an eastern cooperative oncology group (ecog) performance status of 0-2. 2. primary diagnosis of breast cancer confirmed by preoperative pathological examination. 3. serum 25(oh)d levels less than 20 ng/ml (50 nmol/l). 4. patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5. patients with adjuvant chemotherapy or combined targeted therapy. 6. life expectancy of at least 6 months. 7. no other uncontrolled benign diseases at the time of recruitment. 8. all patients must have complete clinical medical records. 9. willingness to voluntarily sign an informed consent form. exclusion criteria: 1. history of invasive breast cancer. 2. prior systemic treatment for the treatment or prevention of breast cancer. 3. known allergic reactions to vitamin d or calcium compounds. 4. comorbidities that may affect vitamin d or calcium balance or bone health. 5. vitamin d or calcium supplementation in the past 3 months. 6. presence of other tumors. 7. pregnant or lactating women. 8. individuals who do not wish to participate in the study.

Keywords: vitamin d breast cancer adverse reaction
randomized trial of adult participants with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder.


Eligibility criteria:
inclusion criteria: * primary diagnosis of generalized anxiety disorder (gad) either moderate or severe as per diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) as confirmed by the mini at screening, in addition to a psychiatric evaluation by a board- certified or biohaven-approved board-eligible psychiatrist; the duration of illness must be ≥ 1 year * hamilton anxiety rating scale (ham-a) total score of ≥ 18 at both screening and baseline * clinical global impression of severity scale (cgi-s) score of ≥ 4 at both screening and baseline * determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. participants must be physically able and expected to complete the trial as designed * minimum of 6 years of education or equivalent to complete necessary scales and understand consent forms * participants must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications * women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at baseline exclusion criteria: * participants with a primary dsm-v psychiatric disorder diagnosis other than gad within the past 6-months. note: participants with a secondary diagnosis of comorbid social anxiety disorder or specific phobia are allowed, if in the investigator's judgement, the diagnosis is not sufficiently prominent and active so as to be confound the assessment of gad symptoms * participants should be excluded at screening or baseline if any medical or psychiatric condition other than gad, as specified in the inclusion criteria, could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of gad symptoms * participants who report a history of inadequate response (per investigator judgement) to 3 or more adequate trials (including current trial) of any ssri or snri, at an adequate dose and adequate duration (at least 8 weeks) for the treatment of gad within the 3 years prior to randomization * hamilton depression rating scale 17 (ham-d-17) item 1 of \>1 at screening or baseline * ham-d-17 of \> 19 at baseline * any eating disorder within the last 12 months prior to screening * acute suicidality in the last 12 months, or suicide attempt or self-injurious behavior in the last 12 months prior to screening * score of \>0 on the sheehan suicidality tracking scale for the period of 12 months prior to screening, and at baseline * history of psychosurgery, deep brain stimulation (dbs) or electroconvulsive therapy (ect)

Keywords: generalized anxiety disorder (gad)
long-term safety of lutetium (177lu) vipivotide tetraxetan in participants with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177lu) vipivotide tetraxetan also known as \[177lu\]lu-psma-617 or 177lu-psma-617 and hereinafter referred to as aaa617. the study also seeks to further characterize (as possible) any other aaa617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of aaa617 from interventional, phase i-iv novartis sponsored clinical trials.

this is a global, prospective, multi-center, long-term follow-up (ltfu) safety study of adult participants with prostate cancer that have received at least one dose of aaa617 from interventional, phase i-iv novartis sponsored clinical trials. there will be no study treatment administered to participants in this study. participants will have visits every 6-8 months for monitoring of selected aes and laboratory parameters. the study periods include a baseline and follow-up period (up to 10 years after first dose of aaa617 in parent treatment study). participants should enroll into the ltfu study after parent treatment study requirements are fulfilled (refer to the parent treatment study protocol for requirements, including any additional requirements after participant enters this ltfu safety study). the schedule of activities for this ltfu study is designed to start from date of informed consent for this ltfu study. participants should be followed every 6 to 8 months for up to a total of 10 years starting from first dose of aaa617 in the parent treatment study. participants entering the ltfu study will have already completed a variable portion of the required 10-year follow-up within the parent treatment study. the specific number of visits required in this ltfu study will depend upon the time of enrollment into this ltfu study following the first dose of aaa617 in the parent treatment study. the total number of participants to be enrolled and the duration of this ltfu study will depend upon the total number treated in the parent treatment studies and their duration.

Eligibility criteria:
inclusion criteria: * signed informed consent must be obtained prior to participation in the study * must have received at least one dose of aaa617 within an interventional, phase i-iv novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study. exclusion criteria: - inability to complete the needed investigational examinations due to any reason.

Keywords: prostate cancer long-term safety follow-up 177lu-psma-617 [177lu]lu-psma-617 lutetium (177lu) vipivotide tetraxetan aaa617 parent treatment study
validity and reliability of lower extremity position test in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Sensory Impairments; Proprioceptive Disorders; Validity; Reliability

Summary: sensory disorders are one of the most important problems in individuals with ms, and these disorders are among the first symptoms of ms. loss of sense of proprioception is particularly common in patients with ms. studies show that assessment methods for the quantitative measurement of sensory disorders are lacking. especially in the clinic, there is no evaluation method that evaluates the sense of proprioception. therefore, the aim of this study perform the validity and reliability study of the lower extremity position test to evaluate proprioception sense in individuals with ms.


Eligibility criteria:
inclusion criteria: * 20-65 years old * edss score between 0-5 * person who has not had an attack in the last 1 month or who is not in the attack period * person without systemic disease such as hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignancy * person who has not undergone surgery that restricts balance function in the lower extremity. * person without hip, knee and ankle contracture * person who does not have additional neurological disease * person who does not use vestibulosupressants or drugs that may cause neuropathy and does not have a history of alcohol use * to have full cooperation and adaptation to the work * individuals who agree to receive treatment will be included in the study. exclusion criteria: * being younger than 20 years old and over 65 years old * being in the attack period * hip, knee or ankle contracture * being greater than edss 5 * having systemic diseases such as hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignancy * having an additional neurological disease * having a vestibulospressant or drug or alcohol use habit that causes neuropathy * not cooperating and adapting to the work
vaginal microbiota and post-cesarean ssi

Conditions: Site Infection; Cesarean Section; Complications, Wound, Infection (Following Delivery)

Summary: the goal of this observational study is to investigate the relationship between vaginal microbiota composition and the development of post-cesarean section wound infection in women undergoing cesarean delivery. the main question it aims to answer is: is there a correlation between specific vaginal microbiota profiles and the incidence of post-cesarean section wound infection? can specific bacterial taxa or diversity indices within the vaginal microbiota predict the risk of post-cesarean section wound infection? participants will: provide vaginal swab samples pre-operatively and post-operatively. undergo standard post-cesarean section care and follow-up. have wound assessment performed per standard of care, and have data collected regarding wound infection status. have demographic and clinical data collected, including but not limited to, antibiotic use, gestational age, and comorbidities.


Eligibility criteria:
inclusion criteria: * pregnant women undergoing elective or emergency cesarean section (cs). * singleton pregnancy. * cesarean section performed at ≥ 37 weeks of gestation. exclusion criteria: * use of antibiotics within two weeks prior to delivery. * known immunodeficiency. * chronic infections. * ruptured membranes for more than 18 hours.

Keywords: cesarean section ssi vaginal microbiota
comparison of mcgrath series 5 and airtraq videolaryngoscope for double-lumen tube (dlt) intubation

Conditions: Intubation;Difficult; Thoracic Disease; Intubation Complication

Summary: previous study showed that mcgrath series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. we have compared it with traditional macintosh laryngoscopefor double-lumen tube intubation. in this study, we will investigate its role in double-lumen tube intubation by comparison with another videolarygoscope.

the investigators designed a randomised controlled study to compare of mcgrath series 5 and airtraq videolaryngoscope for dlt intubation in intubation time and the first attempt success rate.

Eligibility criteria:
inclusion criteria: * adult patients * thoracic surgery required one lung ventilation exclusion criteria: * asa physical status \>4 * emergent operation * planned tracheotomy * difficult intubation predicted by a simplified airway risk index score

Keywords: videolaryngoscope double-lumen tube intubation
viennese registry on patients with chronic critical limb ischemia

Conditions: Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs

Summary: the rationale of this study is to establish a registry to detect and follow patients with cli treated in vienna. the vienna cli registry is meant to document the incidence, prevalence, and actual outcome of cli patients in a real world setting and should serve as a tool for the evaluation of medical, endovascular and surgical interventions. it will help determining the prognosis of individual patients and have impact on economic and political decisions in vienna concerning this disease and the related costs.

this is a prospective observational cohort study including consecutive patients with cli. the study will be initiated as a single center evaluation and is intended to be step-wise expanded to a vienna-wide systematic survey. the study will include patients with chronic critical limb ischemia and ischemic ulcerations as defined by fontaine stage iv or rutherford stages 5 \& 6. the study will include all patients presenting with cli to the participating centers including inpatients and outpatients. patients will be followed up 1 month, 3 months, 6 months, 12 months and then every 6 months. the study will be continued at least until the 5 year data of the last included patient are available.

Eligibility criteria:
inclusion criteria: * chronic (\> 2 weeks) critical limb ischemia in one or both of the lower extremities with necrosis and/or gangrene in the limb (peripheral artery disease iv according to fontaine's classification or rutherford stage 5 \& 6) of whatever genesis (atherosclerotic, aneurysmatic, embolic, inflammatory) * ankle/brachial index \< 0.4 or toe pressure \< 30 mmhg * ability to give written informed consent exclusion criteria: * o ulceration exclusively due to nonvascular causes like neuropathy (without coexisting hemodynamic impairment as defined above) or venous ulceration (without coexisting arterial impairment as defined above)

Keywords: peripheral artery disease stage iv (fontaine's classification) or stage 5 and 6 (rutherford's classification